510k
Database
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Anesthesiology
473
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1434
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336
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1128
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210
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839
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1888
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1425
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125
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87
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426
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360
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236
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2471
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49
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435
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2057
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145
Categories
GEX
Powered Laser Surgical Instrument
306
LLZ
System, Image Processing,...
304
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Polymer Patient Examination Glove
273
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Electrosurgical, Cutting &...
260
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Automated Radiological Image...
255
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System, Imaging, Pulsed Doppler,...
246
HRS
Plate, Fixation, Bone
244
OLO
Orthopedic Stereotaxic Instrument
203
NHA
Abutment, Implant, Dental,...
191
MAX
Intervertebral Fusion Device...
171
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X-Ray Systems
Medical Device Manufacturer
·
US , Fraser , MI
X-Ray Systems - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1985
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - X-Ray Systems
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 12, 1989
HEAD HOLDING DEVICE/SLEEP APNEA
K884493
·
IWY
Radiology
·
78d
Cleared
Feb 12, 1986
UPRIGHT BUCKY STAND/MOUNT
K855161
·
KPR
Radiology
·
48d
Cleared
Feb 06, 1986
TABLE RADIOGRAPHIC FIXED
K855052
·
IXQ
Radiology
·
51d
Cleared
Sep 19, 1985
MOUNT TUBE RADIOGRAPHIC
K853682
·
IYB
Radiology
·
15d
Filters
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4
Radiology
4